Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.

Overview

The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.

Full Title of Study: “The Effects of Low Intensity Exercise in Hypobaric vs. Normobaric Normoxic and Hypoxic Conditions on Baroreflex Sensitivity, Physiological Responses and Cerebral Functions in Pilots.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 14, 2019

Detailed Description

Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.

Interventions

  • Other: Hypoxia
    • Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.

Arms, Groups and Cohorts

  • Other: No arm used
    • No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).

Clinical Trial Outcome Measures

Primary Measures

  • Baro-reflex sensitivity
    • Time Frame: 6 minutes per record.
    • To test the strength of relationship between RR interval and systolic blood pressure in human. Measurement before and after low intensity exercise in each condition.

Secondary Measures

  • Concentration performance
    • Time Frame: 4 minutes per test
    • Subjects will conduct a concentration test in each condition.
  • EEG microstates
    • Time Frame: 6 minutes per record
    • Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.
  • Heart rate variability (HRV)
    • Time Frame: 6 minutes per record
    • To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.
  • Cerebral blood flow
    • Time Frame: 6 minutes per record.
    • Regulation of cerebral blood flow in hypoxia at rest and during low-intensity exercise. Measurement before, during and after low intensity exercise in each condition. 6 minutes recording per measurement.

Participating in This Clinical Trial

Inclusion Criteria

  • Study Indication – Male and Female subjects from 18 years to 40 years of age – Healthy volunteer – Signed Informed Consent after being informed Exclusion Criteria:

  • Contraindications to the study intervention. – Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention, – Women who are pregnant or breast feeding, – Intention to become pregnant during the course of the study, – Known or suspected non-compliance, drug or alcohol abuse, – Previous problem with hypoxia or altitude exposure, – Known pathologies/diseases – Relevant medical disorders – Anemia or poor health – History of flight sickness

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fliegerärztliches Institut
  • Collaborator
    • University of Lausanne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Denis Bron, Dr. med., Principal Investigator, Aeromedical Center

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